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Class I: serious health riskTerminated

Eugene Oregon Mojo Risen Recall

MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville,…

Eugene Oregon, Inc. · Levittown, PA

Risk level
Class I
Reported by FDA
Oct 8, 2014
Recall ID
D-1614-2014
Check your lot numberHow we source this data

Summary

Eugene Oregon recalled Mojo Risen starting May 5, 2014. The FDA classified it as Class I (serious health risk) and published enforcement report D-1614-2014 on Oct 8, 2014. Reason: Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. Status: Terminated.

Why it was recalled

Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Product description

MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1614-2014
Classification
Class I
Status
Terminated
Recall initiated
May 5, 2014
FDA report date
Oct 8, 2014
Quantity
57 boxes
Recall type
Voluntary: Firm initiated
Recalling firm
Eugene Oregon, Inc.

Original FDA data

Every field from FDA enforcement report D-1614-2014, exactly as published.

Show all FDA fields
City
Levittown
State
PA
Status
Terminated
Country
United States
Event ID
68218
Address
54 Spinythorn Road
Code information
All lots
Postal code
19056
Report date
Oct 8, 2014
Product type
Drugs
Recall number
D-1614-2014
Classification
Class I
Recalling firm
Eugene Oregon, Inc.
Product quantity
57 boxes
Termination date
Apr 1, 2015
Reason for recall
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Voluntary / mandated
Voluntary: Firm initiated
Product description
MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
Distribution pattern
To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
Recall initiation date
May 5, 2014
Initial firm notification
Letter
Center classification date
Sep 29, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1614-2014, published Oct 8, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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